Ursodeoxycholic Acid for the Treatment of Parenteral Nutrition–Associated Cholestasis in Pediatric Patients
Bibliographic record
Abstract
Objective: To determine the relative safety and efficacy of ursodeoxycholic acid (UDCA) in children and neonates with parenteral nutrition–associated cholestasis (PNAC). Data Sources: A comprehensive search (up to May 29, 2006) of the following databases was conducted to identify relevant prospective, randomized, double-blind clinical trials and systematic reviews: Ovid–MEDLINE, PubMed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, and the Centre for Reviews and Dissemination. In addition, reference lists from retrieved articles were searched to identify trials or systematic reviews not identified in the search of electronic databases. Also, the manufacturer of UDCA was contacted regarding access to any other unpublished trials that could be included in this review. Study Selection and Data Extraction: Prospective, double-blind, randomized, controlled trials of neonates (<36 wk gestational age) and/or children (0–18 y) who developed PNAC while receiving parenteral nutrition were included in the analysis. Articles were evaluated with specific focus placed on the following hierarchy of outcomes: mortality, nonfatal serious adverse events, liver failure, infection, sepsis, return of liver function test results to within normal ranges, and relief of pruritus. Data Synthesis: No prospective, double-blind, randomized, controlled trials assessing the efficacy and safety of UDCA for the treatment of PNAC in children and/or neonates were identified. Five retrospective chart reviews and/or case series were identified; however, the results of these studies were conflicting and do not provide sufficient evidence of the safety and efficacy of UDCA for the treatment of PNAC. Conclusions: There is no evidence from prospective, double-blind, randomized, controlled trials in neonates and/or children with PNAC regarding the relative safety and efficacy of UDCA therapy.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.017 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".